Novartis reports positive health-related quality of life data for 177Lu-PSMA-617

Encouraging data comes with FDA and EMA submissions reportedly still on track before year end.

Yesterday, the Swiss pharma giant announced positive health-related quality of life (HRQoL) data out of its Phase III VISION study that’s been evaluating its targeted radioligand therapy, 177Lu-PSMA-617, alongside standard of care (SoC) for metastatic castration-resistant prostate cancer (mCRPC) in comparison to SoC alone. Patients in the treatment arm including both 177Lu-PSMA-617 plus SoC were found to have a delay in the worsening of significant pain and reduced physical functioning, which many patients diagnosed with mCRPC suffer from, when compared to the control group. The news come a few months after the Food and Drug Administration granted 177Lu-PSMA-617 a breakthrough designation. The company is also reportedly still on track to see through its submissions to both the FDA and European Medicines Agency before the end of the year.

“Patients with mCRPC suffer from many complications associated with advanced disease that can impact their quality of life,” said Jeff Legos, Global Head of Oncology Development, Novartis. “These new data emphasize the potential impact on quality of life that investigational 177Lu-PSMA-617 may provide as a potential new treatment option, beyond previously reported improvements in overall survival and radiographic progression-free survival.” Two additional studies testing the radioligand therapy in earlier lines of treatment for metastatic prostate cancer are also ongoing. In addition, the Big Pharma is also looking into “opportunities to investigate 177Lu-PSMA-617 radioligand therapy in earlier stages of prostate cancer”. The results from the Phase III VISION trial will be presented at the European Society for Medical Oncology Congress, running from the 17th to the 21st of September 2021.